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Data / Medical devices / Intervertebral Fusion Device With Bone Graft, Lumbar / United States

FDA-registered makers of Intervertebral Fusion Device With Bone Graft, Lumbar in the United States: 241 establishments

241 establishments in the United States are registered with the FDA to make Intervertebral Fusion Device With Bone Graft, Lumbar (product code MAX). 87 have a 510(k) clearance or PMA approval on file and 24 have a recall event. FDA data exported November 2, 2026.

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Device
Intervertebral Fusion Device With Bone Graft, Lumbar
Product code
MAX
Country
United States

Makers of Intervertebral Fusion Device With Bone Graft, Lumbar in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer49July 17, 2026230api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer44June 21, 2022000api.fda.gov
Nuvasive, Inc.San Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer39June 21, 2022000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer, Repackager or relabeler38April 12, 2022010api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesManufacturer, Specification developer31May 21, 2025240api.fda.gov
Life SpineHuntley, IL, United StatesSpecification developer30July 28, 2026000api.fda.gov
Seaspine Orthopedics CorporationCarlsbad, CA, United StatesComplaint file establishment, Manufacturer, Specification developer28June 20, 2024010api.fda.gov
Spinal Elements, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer, Specification developer28May 15, 2026010api.fda.gov
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer21July 17, 2026210api.fda.gov
Nuvasive, Inc.Guaynabo, PR, United StatesManufacturer20June 21, 2022000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesComplaint file establishment, Specification developer17March 8, 2023120api.fda.gov
Alphatec Spine, Inc.Carlsbad, CA, United StatesManufacturer, Specification developer16February 3, 2025030api.fda.gov
Alphatec Spine, Inc.Memphis, TN, United StatesManufacturer16February 3, 2025000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer16September 6, 2024010api.fda.gov
Medtronic Puerto Rico Operations Co., HumacaoHumacao, PR, United StatesManufacturer16May 24, 2021000api.fda.gov
Stryker SpineAllendale, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer16July 25, 2019050api.fda.gov
ZavationFlowood, MS, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer16April 10, 2024000api.fda.gov
Camber Spine TechnologiesKing of Prussia, PA, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer14July 12, 2024000api.fda.gov
Spine Wave, Inc.Shelton, CT, United StatesManufacturer, Repackager or relabeler, Specification developer14May 29, 2026010api.fda.gov
Choice Spine LLCKnoxville, TN, United StatesComplaint file establishment, Specification developer12September 13, 2022000api.fda.gov
CTL Medical CorporationCarrollton, TX, United StatesComplaint file establishment, Manufacturer, Specification developer11October 10, 2024010api.fda.gov
K2M, Inc.Leesburg, VA, United StatesComplaint file establishment, Manufacturer, Specification developer11December 14, 2017010api.fda.gov
Orthofix Us LLCLewisville, TX, United StatesComplaint file establishment, Manufacturer, Specification developer11May 28, 2024030api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer, Manufacturer, Repackager or relabeler11May 21, 2025000api.fda.gov
Carlsmed, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer10July 7, 2025000api.fda.gov
4web Inc.Frisco, TX, United StatesSpecification developer9August 5, 2021010api.fda.gov
Titan Spine, a Division of MedtronicMilwaukee, WI, United StatesManufacturer9April 12, 2022000api.fda.gov
Xtant Medical Holdings, Inc.Belgrade, MT, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer9December 20, 2019020api.fda.gov
Expanding Innovations, Inc.Mountain View, CA, United StatesComplaint file establishment, Manufacturer8June 16, 2025000api.fda.gov
Astura MedicalIrving, TX, United StatesComplaint file establishment, Specification developer7May 9, 2023000api.fda.gov
INNO Holdings Inc.Millcreek, UT, United StatesManufacturer7July 15, 2020010api.fda.gov
Spineology Inc.Saint Paul, MN, United StatesManufacturer7February 19, 2021000api.fda.gov
Genesys SpineAustin, TX, United StatesManufacturer, Specification developer6March 9, 2022010api.fda.gov
Altus PartnersWest Chester, PA, United StatesRepackager or relabeler, Specification developer5February 22, 2019000api.fda.gov
Cutting Edge SpineMineral Spgs, NC, United StatesRepackager or relabeler, Specification developer5May 13, 2020000api.fda.gov
Degen MedicalFlorence, SC, United StatesComplaint file establishment, Specification developer5April 4, 2025000api.fda.gov
Kyocera Medical Technologies, Inc.Redlands, CA, United StatesComplaint file establishment, Specification developer5March 20, 2025000api.fda.gov
Precision Spine, Inc.Pearl, MS, United StatesManufacturer5December 8, 2021000api.fda.gov
Acuity Surgical Devices, LLCIrving, TX, United StatesManufacturer, Repackager or relabeler4June 2, 2025000api.fda.gov
Adcura, Inc.Wayzata, MN, United StatesComplaint file establishment, Manufacturer, Specification developer4October 26, 2022000api.fda.gov
CAPTIVA SPINE, Inc.Jupiter, FL, United StatesComplaint file establishment, Specification developer4November 29, 2023010api.fda.gov
Nexus Spine, L.L.C.Salt Lake City, UT, United StatesComplaint file establishment, Specification developer4March 20, 2024000api.fda.gov
Nexus Spine, LLC.Lehi, UT, United StatesComplaint file establishment, Specification developer4March 20, 2024000api.fda.gov
Nexxt Spine LLCNoblesville, IN, United StatesComplaint file establishment, Manufacturer4May 21, 2020000api.fda.gov
Nvision Biomedical Technologies, IncSan Antonio, TX, United StatesRepackager or relabeler, Specification developer4September 17, 2024000api.fda.gov
Vy Spine, LLCBountiful, UT, United StatesManufacturer, Specification developer4March 18, 2025000api.fda.gov
Amplify SurgicalFoothill Ranch, CA, United StatesComplaint file establishment, Specification developer3October 18, 2022000api.fda.gov
KeosNaples, FL, United StatesSpecification developer3December 16, 2019000api.fda.gov
Mirus, LLCMarietta, GA, United StatesManufacturer3August 20, 2021000api.fda.gov
Nanovis Spine, LLCColumbia City, IN, United StatesComplaint file establishment, Manufacturer, Specification developer3September 5, 2024000api.fda.gov
Pantheon Spinal LLCGeorgetown, TX, United StatesComplaint file establishment, Specification developer3December 16, 2019000api.fda.gov
SpineSmith Holdings, LLCAustin, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer3March 29, 2017000api.fda.gov
Curiteva, Inc.Tanner, AL, United StatesContract manufacturer, Manufacturer2January 18, 2024000api.fda.gov
Eminent Spine, LLCPlano, TX, United StatesManufacturer2May 16, 2023000api.fda.gov
Kalitec Direct LLC DBA Kalitec MedicalSarasota, FL, United StatesComplaint file establishment, Repackager or relabeler, Specification developer2May 27, 2022000api.fda.gov
Met One Technologies, LLCEl Paso, TX, United StatesManufacturer, Specification developer2May 26, 2023000api.fda.gov
NanoHive Medical LLCWoburn, MA, United StatesManufacturer, Specification developer2July 12, 2023000api.fda.gov
Omnia MedicalMorgantown, WV, United StatesSpecification developer2February 21, 2020000api.fda.gov
Retropsoas Technologies, LLCFrontenac, MO, United StatesComplaint file establishment, Specification developer2October 7, 2024000api.fda.gov
Teslake, Inc.San Diego, CA, United StatesSpecification developer2April 23, 2015000api.fda.gov
Wenzel SpineAustin, TX, United StatesSpecification developer2January 28, 2019000api.fda.gov
Xenco Medical LLCSan Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer2August 24, 2018000api.fda.gov
Xenix MedicalOrlando, FL, United StatesComplaint file establishment, Repackager or relabeler, Specification developer2February 23, 2026000api.fda.gov
Zsfab IncWaltham, MA, United StatesSpecification developer2November 25, 2025000api.fda.gov
restor3d, inc.Durham, NC, United StatesComplaint file establishment, Manufacturer2January 22, 2024000api.fda.gov
Advanced Research MedicalBurnsville, MN, United StatesManufacturer1July 25, 2018010api.fda.gov
Aurora Spine, Inc.Carlsbad, CA, United StatesManufacturer, Specification developer1January 31, 2014000api.fda.gov
Blustone Synergy, LLCPueblo, CO, United StatesSpecification developer1September 8, 2017000api.fda.gov
Calvary Spine, LLCTowson, MD, United StatesRepackager or relabeler, Specification developer1October 17, 2008000api.fda.gov
Elliquence LLCBaldwin, NY, United StatesComplaint file establishment, Specification developer1January 24, 2025000api.fda.gov
Evolution Spine, LLCDallas, TX, United StatesComplaint file establishment, Manufacturer, Specification developer1November 16, 2016000api.fda.gov
Intelivation Technologies, LLCPlymouth Meeting, PA, United StatesComplaint file establishment, Manufacturer, Specification developer1October 29, 2021000api.fda.gov
Integrity SpineSan Antonio, TX, United StatesManufacturer1November 10, 2015000api.fda.gov
K7 LLCHenderson, NV, United StatesManufacturer, Specification developer1December 9, 2013000api.fda.gov
KL DistributingHudson, FL, United StatesManufacturer1February 1, 2018000api.fda.gov
Ortho Development Corp.Draper, UT, United StatesComplaint file establishment, Manufacturer1October 25, 2011000api.fda.gov
OrthocircleSavannah, GA, United StatesSpecification developer1October 14, 2022000api.fda.gov
Osseus Fusion Systems LLCDallas, TX, United StatesRepackager or relabeler, Specification developer1August 15, 2018000api.fda.gov
Republic SpineFort Lauderdale, FL, United StatesComplaint file establishment, Manufacturer1September 12, 2019000api.fda.gov
Romd, LLCRochester Hills, MI, United StatesContract manufacturer, Manufacturer1April 21, 2011000api.fda.gov
Southern Spine, LLCMacon, GA, United StatesSpecification developer1November 16, 2021000api.fda.gov
Spine Innovation, LLCCoronado, CA, United StatesComplaint file establishment, Specification developer1January 8, 2026000api.fda.gov
SPINEFRONTIER, INC. DBA LESspine InnovationsBurlington, MA, United StatesManufacturer1June 19, 2020020api.fda.gov
Surgtech, Inc.Westlake, OH, United StatesManufacturer, Specification developer1March 25, 2016000api.fda.gov
Spinal Surgical Strategies, IncIncline Village, NV, United StatesSpecification developer1September 14, 2021000api.fda.gov
Thompson MisSandown, NH, United StatesSpecification developer1October 26, 2011000api.fda.gov
Valorus Spine, LLCDanville, CA, United StatesManufacturer1October 25, 2017000api.fda.gov
Alden Tool Company, Inc.Berlin, CT, United StatesContract manufacturer0000api.fda.gov
American Manufacturing And EngineeringMontgomeryville, PA, United StatesContract manufacturer0000api.fda.gov
Aps Materials, Inc.Dayton, OH, United StatesContract manufacturer0000api.fda.gov
Ar FabricatingGeorgetown, TX, United StatesContract manufacturer0000api.fda.gov
ARCH - QuakertownQuakertown, PA, United StatesContract manufacturer0000api.fda.gov
Arch Medical Solutions - Philadelphia, LLC Dba Jade Precision Medical ComponentsHuntingdon Valley, PA, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - ElmhurstElmhurst, IL, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisBartlett, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisLexington, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - Olive BranchOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - SeabrookSeabrook, NH, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - WarsawWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Avalign Integrated Medical Solutions, IncMentor, OH, United StatesContract manufacturer0000api.fda.gov
AVALIGN TECHNOLOGIES, Inc.Fort Wayne, IN, United StatesSpecification developer0000api.fda.gov
Axial MedicalIvyland, PA, United StatesContract manufacturer0000api.fda.gov
Acero PrecisionWest Chester, PA, United StatesContract manufacturer0000api.fda.gov
Autocam MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Avalign Additive / Slice Manufacturing StudiosAkron, OH, United StatesContract manufacturer0000api.fda.gov
Avalign Delivery Systems DivisionGreenwood, IN, United StatesContract manufacturer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
B & G MFG. Co.Hatfield, PA, United StatesContract manufacturer0000api.fda.gov
B & J Medical LLCKendallville, IN, United StatesContract manufacturer0000api.fda.gov
Banister Tool, Inc.Pflugerville, TX, United StatesContract manufacturer0000api.fda.gov
Biogennix, LLCIrvine, CA, United StatesManufacturer0000api.fda.gov
Biopro, Inc.Port Huron, MI, United StatesContract manufacturer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer0000api.fda.gov
Boulder Biomed LLCBoulder, CO, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Branch Medical GroupEagleville, PA, United StatesContract manufacturer0000api.fda.gov
Branch Medical GroupLimerick, PA, United StatesContract manufacturer0000api.fda.gov
Bradshaw Medical Inc.Kenosha, WI, United StatesContract manufacturer0000api.fda.gov
C&A Tool Engineering, Inc. Auburn PlantAuburn, IN, United StatesContract manufacturer, Manufacturer for export0000api.fda.gov
C&W Swiss, Inc.Clayton, OH, United StatesContract manufacturer0000api.fda.gov
C+a Tool Engineering, Inc.Churubusco, IN, United StatesContract manufacturer, Manufacturer for export0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer0000api.fda.gov
Complexus MedicalMishawaka, IN, United StatesContract manufacturer0000api.fda.gov
Depuy Orthopaedics, Inc.Raynham, MA, United StatesManufacturer0010api.fda.gov
Design And Services Hub, LLCHartville, OH, United StatesContract manufacturer0000api.fda.gov
Donson Machine CompanyAlsip, IL, United StatesContract manufacturer0000api.fda.gov
Eptam Plastics, LtdNorthfield, NH, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCFlorence, AL, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCCordova, TN, United StatesContract manufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Ferry Machine CorporationOakland, NJ, United StatesContract manufacturer0000api.fda.gov
First Article IncSouderton, PA, United StatesContract manufacturer0000api.fda.gov
Flex-Cell Precision, Inc.Lancaster, PA, United StatesContract manufacturer0000api.fda.gov
Foundation Surgical GroupScottsdale, AZ, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ferry Machine CorporationLittle Ferry, NJ, United StatesContract manufacturer0000api.fda.gov
G Surgical LLCAustin, TX, United StatesManufacturer, Specification developer0000api.fda.gov
Gauthier Biomedical, Inc.Grafton, WI, United StatesContract manufacturer0000api.fda.gov
Geotec, Inc.Warwick, RI, United StatesContract manufacturer0000api.fda.gov
Guardian Medical Usa, IncSwanton, OH, United StatesContract manufacturer0000api.fda.gov
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.fda.gov
HC Biologics LLCMiami, FL, United StatesManufacturer0000api.fda.gov
Hoosier, Inc.Corona, CA, United StatesContract manufacturer0000api.fda.gov
Insert Molding Solutions, Inc.Cumming, GA, United StatesContract manufacturer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Isotis Orthobiologics, IncIrvine, CA, United StatesContract manufacturer0000api.fda.gov
J & J Precision Technologies, LLCLititz, PA, United StatesContract manufacturer0000api.fda.gov
J&B Precision, Inc.Cordova, TN, United StatesContract manufacturer0000api.fda.gov
Jarvis Surgical Inc.Westfield, MA, United StatesContract manufacturer0000api.fda.gov
Jatex, Inc.Nappanee, IN, United StatesContract manufacturer0000api.fda.gov
Jewel Precision Sheet Metal & Machining, Inc.Cedar Grove, NJ, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Brandywine)W Chester, PA, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Elmira)Horseheads, NY, United StatesContract manufacturer0000api.fda.gov
LH Medical CorporationFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Linear Precision, Inc.Florence, SC, United StatesContract manufacturer0000api.fda.gov
LISI MEDICAL REmmeleBig Lake, MN, United StatesContract manufacturer0000api.fda.gov
LISI MEDICAL RemmeleCoon Rapids, MN, United StatesContract manufacturer0000api.fda.gov
Lincotek MedicalBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Lincotek Medical LLCVandalia, OH, United StatesContract manufacturer0000api.fda.gov
Mackay Manufacturing, Inc.Spokane Valley, WA, United StatesContract manufacturer0000api.fda.gov
Mainstream Medical DevicesAustin, TX, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Maitland EngineeringSouth Bend, IN, United StatesContract manufacturer0000api.fda.gov
Medical Device And Implants LLCLancaster, PA, United StatesContract manufacturer0000api.fda.gov
Medical Modeling - A 3D Systems CompanyLittleton, CO, United StatesContract manufacturer0000api.fda.gov
Medtech LLCMillington, TN, United StatesContract manufacturer0000api.fda.gov
Medtronic Navigation, Inc.Lafayette, CO, United StatesManufacturer0000api.fda.gov
Micro Precision SwissSanta Ana, CA, United StatesContract manufacturer0000api.fda.gov
Micropulse IncColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Machining Midtown LLCAtlanta, GA, United StatesContract manufacturer0000api.fda.gov
Medtronic Grand RapidsGrand Rapids, MI, United StatesManufacturer0000api.fda.gov
Medynus, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
MendellLakeville, MN, United StatesContract manufacturer0000api.fda.gov
Metal Craft Machine & Engineering, Inc.Elk River, MN, United StatesContract manufacturer0000api.fda.gov
Microcision LLCPennsauken, NJ, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Ngage Medical ManufacturingHernando, MS, United StatesContract manufacturer0000api.fda.gov
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
NML Medical, LLCWest Carrollton, OH, United StatesContract manufacturer0000api.fda.gov
Novapproach Spine, LLCAlachua, FL, United StatesSpecification developer0000api.fda.gov
NextPhase Medical Devices LLCRochester, NH, United StatesContract manufacturer0000api.fda.gov
Nypro Healthcare Baja Inc. (Albuquerque)Albuquerque, NM, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Odyssey Medical Technologies, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Osteomni IncMiami, FL, United StatesSpecification developer0000api.fda.gov
Orchid Orthopedic Solutions Alabama LLCArab, AL, United StatesContract manufacturer0000api.fda.gov
Pacific Instruments Inc.Honolulu, HI, United StatesContract manufacturer0000api.fda.gov
Packaging Compliance Medical, LLCKentwood, MI, United StatesContract manufacturer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Perryman CompanyHouston, PA, United StatesContract manufacturer0000api.fda.gov
Precision Edge Surgical Products CompanySault Sainte Marie, MI, United StatesContract manufacturer0000api.fda.gov
Precision Medical TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Pro Surgical, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Pro-Tech Design & MFG., Inc.Santa Fe Springs, CA, United StatesContract manufacturer0000api.fda.gov
PT Solutions, LLCBrunswick, OH, United StatesContract manufacturer0000api.fda.gov
Pulse Technologies, Inc.Quakertown, PA, United StatesContract manufacturer0000api.fda.gov
Paragon Medical - DaytonDayton, OH, United StatesContract manufacturer0000api.fda.gov
Paragon Medical Inc.Smithfield, UT, United StatesContract manufacturer0000api.fda.gov
Phillips Precision IncElmwood Park, NJ, United StatesContract manufacturer0000api.fda.gov
Pioneer Surgical Technology, Inc.Marquette, MI, United StatesContract manufacturer0010api.fda.gov
Precision Medical Technologies- North Manchester Manufacturing FacilityN Manchester, IN, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
R.K. ManufacturingDanbury, CT, United StatesContract manufacturer0000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesContract manufacturer0000api.fda.gov
Riverside Machine & Engineering, Inc.Eau Claire, WI, United StatesContract manufacturer0000api.fda.gov
RMS Co.Minneapolis, MN, United StatesContract manufacturer0000api.fda.gov
RSB Spine LLC.Wooster, OH, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesContract manufacturer0000api.fda.gov
SINTX Technologies Inc.Salt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Spinecraft LLCWestmont, IL, United StatesManufacturer, Specification developer0000api.fda.gov
Stoll Metalcraft, Inc.Santa Clarita, CA, United StatesContract manufacturer0000api.fda.gov
Structure Medical, LLC.Naples, FL, United StatesContract manufacturer0000api.fda.gov
Surgical Instrument Manufacturers, LLCFenton, MO, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical, Inc. - ManchesterManchester, NH, United StatesContract manufacturer0000api.fda.gov
Sites Medical, LLCColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Structure Medical, LLC.Mooresville, NC, United StatesContract manufacturer0000api.fda.gov
The Orthopaedic Implant CompanyReno, NV, United StatesSpecification developer0000api.fda.gov
TOMZ CorporationBerlin, CT, United StatesContract manufacturer0000api.fda.gov
Troy Innovative Instruments Co LLCMiddlefield, OH, United StatesContract manufacturer0000api.fda.gov
Turnco Tool & Instrument, Inc.Georgetown, TX, United StatesContract manufacturer0000api.fda.gov
Turner Medical Inc.Athens, AL, United StatesContract manufacturer0000api.fda.gov
Tangible Solutions, Inc. DBA Marle Tangible, Inc.Fairborn, OH, United StatesContract manufacturer0000api.fda.gov
Tech Industries. Inc.Cleveland, OH, United StatesContract manufacturer0000api.fda.gov
Tegra MedicalHernando, MS, United StatesContract manufacturer0000api.fda.gov
The E F PRECISION GROUPWillow Grove, PA, United StatesContract manufacturer0000api.fda.gov
Tyber MedicalBethlehem, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Tyber MedicalBethlehem, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Unity Tool, Inc.Osseo, MN, United StatesContract manufacturer0000api.fda.gov
Victoria Precision Inc.Trevose, PA, United StatesContract manufacturer0000api.fda.gov
VIPER TECHNOLOGIES, LLC. (d.b.a Avalign Thortex)Parkrose, OR, United StatesContract manufacturer0000api.fda.gov
VorzeigenConnersville, IN, United StatesContract manufacturer0000api.fda.gov
Viant Medical, LLCFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Westwood Precision LLCAllentown, PA, United StatesContract manufacturer0000api.fda.gov
Wheelhouse MedicalMonroe, NC, United StatesContract manufacturer0000api.fda.gov
Watershed Idea Foundry, Inc.Carlsbad, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Xyresic LLCJackson, MI, United StatesContract manufacturer0000api.fda.gov
Zigg Design LLCNibley, UT, United StatesContract manufacturer0000api.fda.gov
Zimmer Trabecular Metal Technology, Inc.Parsippany, NJ, United StatesContract manufacturer, Manufacturer for export0010api.fda.gov
rms SurgicalAnoka, MN, United StatesContract manufacturer0000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.